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510(k) K942338

OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES by Olympus Corp. — Product Code FDT

K942338 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code FDT (Duodenoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
May 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Duodenoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)
  • K933992 — OLYMPUS SCLEROTHERAPY BALLOON (December 21, 1993)

Other clearances for product code FDT

  • K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM (March 9, 2026)
  • K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315) (February 22, 2026)
  • K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (September 19, 2025)
  • K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (June 5, 2025)
  • K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (August 1, 2024)
  • K233886 — Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (April 16, 2024)
  • K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (May 11, 2022)
  • K210710 — PENTAX Medical Video Duedenoscope ED34-i10T2 (April 9, 2021)
  • K202365 — Pentax Medical Video Duodenoscope ED32-i10 (April 1, 2021)
  • K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (December 8, 2020)

FDA data resources